Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4

FDA 510(k) K042714 · Spine Next America Corporation

Substantially Equivalent

510(k) numberK042714

Submission

Device name
Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4
Applicant
Spine Next America Corporation
Jacksonville, FL, US
Received
September 24, 2004
Decision date
December 29, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MQP – Spinal Vertebral Body Replacement Device
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3060
Specialty
Orthopedic
Implant
Yes

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K231134VerteLoc Spinal SystemMQP · Traditional Signature Orthopaedics Pty, Ltd.02/13/2024SE
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K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)MQP · Traditional Arftx Medical, LLC10/06/2022SE
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More from Corelink, LLC

510(k)DeviceDecision
K042713Fidji-Vertebral Body Replacement Type 5MQP · Traditional 12/29/2004SE
K033965Shiraz-Anterior SystemKWQ · Traditional 03/04/2004SE
K033947Shiraz Posterior SystemMNI · Traditional 03/04/2004SE
K033772Shiraz-Java Spinal Fixation SystemMNI · Traditional 01/27/2004SE

Questions and answers

When was Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4 cleared by the FDA?

Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4 (K042714) received a 510(k) decision of Substantially Equivalent on December 29, 2004, 96 days after the submission was received.

What is the product code of K042714?

The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.